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Endpoint Adjudication of Events Charter Template: What Should Be Included?Endpoint adjudication is gaining importance in pharma today, however, no guidance on endpoint adjudication currently exists. The LinkedIn Endpoint Adjudication Community has generated an Events Charter Template to shed light on the subject for those in need of guidance.
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De-identifying Data in Clinical TrialsWhether we are referring to CSRs or to IPD, the personal information of trial participants needs to be de-identified prior to release. This article will describe the available methods for de-identifying clinical trial data, and the relative strengths and weaknesses of each.
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Bridging the Gaps in CAPA Planning in Clinical TrialsLeveraging approaches in RBQM to enable effective corrective and preventive action processes.
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Patient Safety Considerations for Follow-On Non-Biologic Complex DrugsBiologic drugs and non-biologic complex drugs have revolutionized the treatment of many difficult-to-treat diseases including cancer, multiple sclerosis, and chronic iron deficiency.
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Harnessing Patient-Centered Science to Improve Health Outcomes and Commercial Pharma SuccessGood scientific principles and practices are essential for maintaining quality data that patients can benefit from.
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Refined Safety AssessmentsA case study of how cardiac safety assessments can be enhanced with Holter Bin.
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Determining Participation in UkraineSurvey shows what keeps Ukrainians away from clinical trials
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Speeding Clinical Trials Through eClinical SystemsUnderstanding the roles of eTMF, CTMS, and study startup solutions in the clinical trials process
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The Challenge and Opportunity Presented by Clinical Trial Regulation EU 536/2014New regulations offer opportunity for simplification in strategic planning.
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Best Practices in Study FeasibilitySurvey drills down on the preferred methods of sponsors, CROs, and sites in conducting feasibility analysis.
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The Evolution of Imaging Techniques in Clinical TrialsEvaluating the use of new tumor measurement tools for studies of molecular-targeted cancer therapies.
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Three Ways AI is Revolutionizing Clinical DevelopmentHow targeted AI can improve the performance of clinical trials.
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Proscia Launches Commercial Research Edition of Digital Pathology PlatformChief Product Officer for Proscia, Nathan Buchbinder, discusses Proscia’s Concentriq and its benefits for CROs and life science organziations.
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Maximizing Recruitment of Targeted Oncology PopulationsWhile some countries are more progressive in approaching this challenge by virtue of mandatory, free of charge, molecular testing on all patients, this varies greatly in other countries based on institutional policy and insurance reimbursement.
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eSource Records in Clinical Research: Keeping it SimpleHow to satisfy regulatory concerns about EDC data integrity and site controls over its source records.
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Clinical Trial Data StewardshipAmid the push for clinical trials to adopt more modern digital data technologies, the job of assuring adherence to key data quality and integrity principles is achievable under current regulations governing electronic record-keeping. Doing so, however, will require a new and reinvented framework: data stewardship.
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The Transformation of Clinical Trials from Writing on Papyrus to the World of TechnologyNew requirements must be put in place to ensure data quality and integrity.
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eSource Records in Clinical Research: Keeping it SimpleHow to satisfy regulatory concerns about EDC data integrity and site controls over its source records.
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eSource Records in Clinical Research: Keeping it SimpleHow to satisfy regulatory concerns about EDC data integrity and site controls over its source records.
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Specialized Safety Needs for Small and Midsize CompaniesMeeting today’s complex regulatory demands when it comes to drug safety and pharmacovigilance can be especially challenging for small and medium-sized organizations. This report presents the benefits for these companies in outsourcing such activities to functional service providers (FSPs) during clinical trials and post-approval.
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The Limited Impact of COVID-19 on US Clinical Trial ActivityResearch shows there was no decline in non-COVID related study spending during height of pandemic.
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Endpoints in Cancer Trials: Putting Patients FirstIn the debate over patient-centric considerations in cancer care, one main focus has been the choice of proper endpoints for clinical trials.
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Optimal COA Measurement Strategy in Modern Oncology TrialsExamining the two areas of weakness cited in FDA draft guidance.
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The DCT Network: When Experienced Providers Come Together, We Can Revolutionize Clinical ResearchPatients reap benefits of strong collaboration in executing DCTs.
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Genomes, Big Data and the Journey to Precision MedicineThis month marks a landmark in the quest for personalized medicine and the growing role of big data in health sciences – from clinical development through tracking patient outcomes long after a therapy has reached the market.
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Wearables: Where is Clinical Development Headed Next?The application of personal device technology in the health care space continues to evolve, fed by the development of health-related consumer products and services by segments of industry traditionally not focused on health
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Closing the Variance Gap: The Challenges with Clinical Trial Budget Management and ForecastingAs clinical trials continue to grow in complexity, tolerance for the growing variance between forecasted and actual clinical trial costs is shrinking.
